Nearly six years ago, in 2015, the FDA attempted to slip a change to its “intended use” regulations (21 C.F.R. §§201.128, 801.4) – which had not been updated since the 1950s – through the administrative process by hiding it in a Federal Register notice about electronic cigarettes. 80 Fed. Reg. 57756 (FDA Sept. 25, 2015).
With apologies, this time, to Sir Paul − “The circuit judge, who held a grudge, has put the FDA’s banned on the run. . . .”
That’s just about what happened in Judge Rotenberg Educational Center, Inc. v. United States FDA, ___ F.4th ___, 2021 WL 2799891 (D.C. Cir. July 6, 2021) (note the
The United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), determined that “off-label usage” is “accepted and necessary” by both the FDA and the medical community. Id. at 350. Thus, “[p]hysicians may prescribe drugs and devices for off-label uses.” Id. at 351 n.5 (citation and quotation marks omitted).
Back in 1998, Bexis published the first major law review article about off-label use of drugs and medical devices and tort liability, James Beck & Elizabeth Azari, “FDA, Off-Label Use, & Informed Consent: Debunking Myths & Misconceptions,” 53 Food & Drug L.J. 71 (1998). This article came to be cited twice by the United States
Delaware is having something of a moment in the sun. Although the state’s license plates have long announced it as “The First State,” that refers to being the first to ratify the U.S. Constitution. It is the second smallest in size and sixth smallest in population of the current fifty states. The casual peruser of
A long time ago in a law school relatively far away, we took torts as a first year law student. Many of the cases about which we learned (or were supposed to have learned) were from even longer ago and we had no idea how much some of those old cases would inform our practice.
It’s a unique relationship based largely on knowledge and trust. Doctor’s not only have to rely on their medical knowledge, but they need to apply that to their knowledge of the patient. Knowledge that often develops overtime through trust. Patients want and need to be able to trust their doctors. Sometimes patients share information with
Can a court decision be simultaneously depressing and exhilarating? You might be surprised how often that happens. In United States v. Facteau, 2020 WL 5517573, (D. Mass. Sept. 14, 2020), the court upheld criminalization of off-label promotion, but did so in a way that might signal the end of an era in which pharmaceutical
Some of us belong to the Food and Drug Law Institute. One benefit of FDLI membership is a daily newsletter on FDA-related issues. The other day that newsletter’s top two links were both COVID-19 related – and we found both of them concerning.
The first item the newsletter featured was this story on “The
We’ve been watching the evolution of the Supreme Court’s thinking on First Amendment review of “speaker” and “content” specific prior restraints since we first noticed that emerging doctrine in the pharmaceutical detailing case, Sorrell v. IMS Health, Inc., 564 U.S. 552 (2011). In Sorrell, however, it was unclear how much (if any) more